Smart ETT ventilation attachment and method of use

ABSTRACT

An add-on device and method for an Endo-Tracheal Tube (ETT), the add-on device including a lengthy body having a major arc-shaped cross section sized and shaped to tightly fit over an ETT, at least one longitudinal cavity passing along the lengthy body, including a distal suction cavity ending with a suction inlet at a distal end of the lengthy body; and a distal suction outlet channel extending from a proximal end of the lengthy body, the channel is a continuous extension of the distal suction cavity and configured to provide suction to the distal suction cavity. The add-on device senses moisture at a distal end of the add-on device, and in case of detection of excessive wetness, provides suction to the distal end of the device through a cavity passing along the device, the suction is provided via a suction outlet channel extending from a proximal end of the device.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/571,211 filed on Sep. 16, 2019, which is a continuation of U.S.patent application Ser. No. 15/279,525 filed on Sep. 29, 2016, now U.S.Pat. No. 10,413,688 which claims the benefit of priority under 35 USC §119(e) of U.S. Provisional Patent Application No. 62/333,625 filed onMay 9, 2016, the contents of which are incorporated herein by referencein their entirety.

FIELD AND BACKGROUND OF THE INVENTION

When a patient has difficulty breathing autonomously, it is a commonpractice to insert an external tubular tracheal ventilation tube, alsoknown as Endo-Tracheal Tube (ETT). An ETT provides fresh air by a forcedventilation pump, and ejects air saturated with CO₂. Thus, the breathingoperation is performed instead of the patient and the needed oxygen isprovided to the patient's organs.

During the forced ventilation process, excessive fluids and secretionare usually aggregated in the mouth and trachea of the patient. Some ofthe known ETTs include a “balloon”, i.e. an inflatable section, intendedfor blocking the fluids from entering further to the trachea and lungs.

SUMMARY OF THE INVENTION

According to an aspect of some embodiments of the present inventionthere is provided an add-on device for an Endo-Tracheal Tube (ETT), theadd-on device including a lengthy body having a major arc-shaped crosssection sized and shaped to tightly fit over an ETT, at least onelongitudinal cavity passing along the lengthy body, comprising a distalsuction cavity ending with a suction inlet at a distal end of thelengthy body, and a distal suction outlet channel extending from aproximal end of the lengthy body, the channel is a continuous extensionof the distal suction cavity and configured to provide suction to thedistal suction cavity.

In some embodiments of the present invention, the device includes amoisture sensor for detection of liquid at the distal end of the lengthybody and at least one sensor data channel going through at least one ofthe longitudinal cavities towards the proximal end of the device.

In some embodiments of the present invention, the device includes amouth suction tube extending from an external surface of the lengthybody at a location corresponding to a patient's mouth, wherein the atleast one longitudinal cavity further comprising a mouth suction cavitycontinuous to the mouth suction tube, and a mouth suction outlet channelextending from the proximal end of the lengthy body, the mouth suctionoutlet channel is a continuous extension of the mouth suction cavity andconfigured to provide suction to the mouth suction cavity.

In some embodiments of the present invention, the device includes amoisture sensor at the distal end of the mouth tube and at least onesensor data channel going through at least one of the longitudinalcavities towards the proximal end of the device.

In some embodiments of the present invention, the mouth suction tube isconnected to the lengthy body by an axis perpendicular to the lengthybody at the connection point, the mouth suction tube tiltable about theaxis to adjust the position of the mouth suction tube.

In some embodiments of the present invention, the device includes aliquid outlet at an external surface of the lengthy body at a locationcorresponding to a patient's mouth, wherein the at least onelongitudinal cavity further comprising a liquid channel cavitycontinuous to the liquid outlet, and a liquid channel extending from theproximal end of the lengthy body, the liquid channel is a continuousextension of the liquid channel cavity and configured to provide liquidto the liquid outlet.

In some embodiments of the present invention, the liquid outlet isconnected to the lengthy body by an axis perpendicular to the lengthybody at the connection point, the liquid outlet tiltable about the axisto adjust the position of the liquid outlet.

In some embodiments of the present invention, the device includes at adistal end of the lengthy body a recess formed in an internal wall ofthe lengthy body, configured to prevent clogging of the suction inlet.

In some embodiments of the present invention, the device includes aninlet at the distal end of the lengthy body and a CO2 sampling pipecontinuous to the inlet going through at least one of the longitudinalcavities towards the proximal end of the device.

In some embodiments of the present invention, the device includes anoutlet bundle of outlet channels including the distal suction outletchannel, the outlet bundle extending from the proximal end of thelengthy body.

In some embodiments of the present invention, the at least onelongitudinal cavity pass in a thickness of the lengthy body.

According to an aspect of some embodiments of the present inventionthere is provided an add-on device for an Endo-Tracheal Tube (ETT), theadd-on device including a liquid outlet at a location corresponding to apatient's mouth, a moisture sensor at a location corresponding to apatient's mouth, and at least one longitudinal cavity passing along thedevice and including a liquid channel cavity continuous to the liquidoutlet, and a moisture sensor data channel, the liquid channel and datachannel going through the at least one longitudinal cavities towards theproximal end of the device, wherein the liquid channel is adapted toguide liquid from a liquid source to the liquid outlet according to datatransmitted through the moisture sensor data channel.

According to an aspect of some embodiments of the present inventionthere is provided a system including an add-on device for anEndo-Tracheal Tube (ETT), the add-on device including at least onelongitudinal cavity passing along the device, comprising a distalsuction cavity ending with a suction inlet at a distal end of thedevice, and a distal suction outlet channel extending from a proximalend of the device, the channel is a continuous extension of the distalsuction cavity and configured to provide suction to the distal suctioncavity, and a hub for operating the add-on device, the hub comprises acontroller configured to control suction supply to the distal suctionoutlet channel according to moisture sensor data.

In some embodiments of the present invention, the device includes alengthy body having a major arc-shaped cross-section.

In some embodiments of the present invention, the controller isconfigured to detect excessive wetness based on moisture sensor data,and when excessive wetness is detected, activate suction through thedistal suction outlet channel.

In some embodiments of the present invention, the device includes amouth suction tube extending from an external surface of the device at alocation corresponding to a patient's mouth, wherein the at least onelongitudinal cavity further comprising a mouth suction cavity continuousto the mouth suction tube, and a mouth suction outlet channel extendingfrom the proximal end of the device, the mouth suction outlet channel isa continuous extension of the mouth suction cavity and configured toprovide suction to the mouth suction cavity, wherein the controller isconfigured to switch a selection valve to select between the distalsuction outlet channel and the mouth suction outlet channel, and switcha pinch valve to control suction supply to the selected suction outletchannel.

In some embodiments of the present invention, the device includes aliquid outlet at an external surface of the device at a locationcorresponding to a patient's mouth, wherein the at least onelongitudinal cavity further comprising a liquid channel cavitycontinuous to the liquid outlet, and a liquid channel extending from theproximal end of the device, the liquid channel is a continuous extensionof the liquid channel cavity and configured to provide liquid to theliquid outlet, wherein the controller is configured to activate a liquidsource to provide liquid via the liquid channel.

In some embodiments of the present invention, the hub includes an aircompressor, wherein the controller is configured to activate the aircompressor to push liquid forcefully through the liquid channel.

In some embodiments of the present invention, the device includes aninlet at the distal end of the device and a CO2 sampling pipe continuousto the inlet going through at least one of the longitudinal cavitiestowards the proximal end of the device, and wherein the hub comprises aCO2 level sensor configured to receive a sample of air via the CO2sampling pipe and to measure CO2 level in the sample.

In some embodiments of the present invention, the controller isconfigured to detect air leakage based on the measured CO2 level.

In some embodiments of the present invention, the controller isconfigured to control inflation of an inflatable section of the ETTbased on sensor data.

According to an aspect of some embodiments of the present inventionthere is provided a method for controlling an add-on device for anEndo-Tracheal Tube (ETT), the method including, when the add-on deviceis installed on the ETT, sensing moisture at a distal end of the add-ondevice, and in case of detection of excessive wetness, provide suctionto the distal end of the device through a cavity passing along thedevice, the suction is provided via a suction outlet channel extendingfrom a proximal end of the device.

In yet another embodiments the said suction channels, the fluid channelas well as the moisture sensors are embedded in the ETT tube directlyand connected to the hub by said cable.

In yet another embodiment a liquid absorbing media such as a sponge isreplacing the balloon.

Unless otherwise defined, all technical and/or scientific terms usedherein have the same meaning as commonly understood by one of ordinaryskill in the art to which the invention pertains. Although methods andmaterials similar or equivalent to those described herein can be used inthe practice or testing of embodiments of the invention, exemplarymethods and/or materials are described below. In case of conflict, thepatent specification, including definitions, will control. In addition,the materials, methods, and examples are illustrative only and are notintended to be necessarily limiting.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

Some embodiments of the invention are herein described, by way ofexample only, with reference to the accompanying drawings. With specificreference now to the drawings in detail, it is stressed that theparticulars shown are by way of example and for purposes of illustrativediscussion of embodiments of the invention. In this regard, thedescription taken with the drawings makes apparent to those skilled inthe art how embodiments of the invention may be practiced.

In the drawings:

FIG. 1 is a schematic illustration of an ETT as known in the art;

FIG. 2 is a schematic illustration of a ventilation enhancement deviceinstalled on or integral with an ETT, according to some embodiments ofthe present invention;

FIG. 3 is a schematic flowchart illustrating a method for controlling aventilation enhancement device according to some embodiments of thepresent invention;

FIG. 4 is a schematic illustration of a hub according to someembodiments of the present invention;

FIG. 5 is a schematic more detailed illustration of an add-on device andan exemplary cross-section of a proximal end of a wrap according to someembodiments of the present invention;

FIG. 6 is a schematic more detailed illustration of an outlet bundle,according to some embodiments of the present invention;

FIGS. 7A and 7B are schematic cross-sectional illustrations of exemplaryproximal and distal ends of a wrap according to some embodiments of thepresent invention;

FIGS. 8A-8D are additional schematic views of an add-on device,according to some embodiments of the present invention; and

FIGS. 9A and 9B are schematic cross-sectional illustrations of anexemplary add-on device including a liquid absorbing material accordingto some embodiments of the present invention.

DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

The existing ETT ventilation tubes have some shortcomings. Secretion maybe accumulated on the balloon and eventually may get into the lungs.Saliva and mucus may be accumulated in the mouth, and in some cases, forexample when the patient doesn't eat and/or drink through the mouth,excessive dryness may be formed, which may cause infections.

In to some embodiments of the present invention a ventilationenhancement device is provided, which may be an add-on device forinstallation on the ETT with minimal or no interruption to theventilation process, or may be integral with the ETT. The ventilationenhancement device according to some embodiments of the presentinvention enables removal of excessive fluids and secretion from thetrachea and mouth during the ventilation by the ETT with no need toreplace a currently installed ETT.

The provided add-on device may include a wrap with a c-shapedcross-section and/or a longitudinal slit, which may simply be snappedupon the ETT without requiring any additional installation steps.

The enhancement device may remove the fluids from the trachea by asuction inlet in the vicinity of the device's end. The fluidsaccumulated in the mouth may be removed by the enhancement device by asuction inlet on the wrap in a location corresponding to the patient'smouth. In order to avoid dryness in the mouth, fluid may be sprayed,periodically and/or when needed, out of an opening in the externalsurface of the wrap, in a location corresponding to the patient's mouth.

According to some embodiments of the present invention, suction may beprovided to the enhancement device by a controller, according to signalsreceived from dedicated sensors located at the vicinity of the suctioninlets. Excessive fluids and secretion in the trachea and mouth may bedetected, for example, by impedance measurements.

In some embodiments of the present invention, the enhancement device maydetect an unwanted gap between the trachea wall and the balloon of theETT. Such gap may cause leakage of secretion into the lungs. Thedetection of an unwanted gap is done by detection of air leaking fromthe gap, by detection of CO2 levels in the vicinity of the balloon.Detector signals may be provided to a controller, which may control thesuction accordingly.

Before explaining at least one embodiment of the invention in detail, itis to be understood that the invention is not necessarily limited in itsapplication to the details of construction and the arrangement of thecomponents and/or methods set forth in the following description and/orillustrated in the drawings and/or the Examples. The invention iscapable of other embodiments or of being practiced or carried out invarious ways.

The present invention may be a system, a method, and/or a computerprogram product. The computer program product may include a computerreadable storage medium (or media) having computer readable programinstructions thereon for causing a processor to carry out aspects of thepresent invention.

The computer readable storage medium can be a tangible device that canretain and store instructions for use by an instruction executiondevice. The computer readable storage medium may be, for example, but isnot limited to, an electronic storage device, a magnetic storage device,an optical storage device, an electromagnetic storage device, asemiconductor storage device, or any suitable combination of theforegoing. A non-exhaustive list of more specific examples of thecomputer readable storage medium includes the following: a portablecomputer diskette, a hard disk, a random access memory (RAM), aread-only memory (ROM), an erasable programmable read-only memory (EPROMor Flash memory), a static random access memory (SRAM), a portablecompact disc read-only memory (CD-ROM), a digital versatile disk (DVD),a memory stick, a floppy disk, a mechanically encoded device such aspunch-cards or raised structures in a groove having instructionsrecorded thereon, and any suitable combination of the foregoing. Acomputer readable storage medium, as used herein, is not to be construedas being transitory signals per se, such as radio waves or other freelypropagating electromagnetic waves, electromagnetic waves propagatingthrough a waveguide or other transmission media (e.g., light pulsespassing through a fiber-optic cable), or electrical signals transmittedthrough a wire.

Computer readable program instructions described herein can bedownloaded to respective computing/processing devices from a computerreadable storage medium or to an external computer or external storagedevice via a network, for example, the Internet, a local area network, awide area network and/or a wireless network. The network may comprisecopper transmission cables, optical transmission fibers, wirelesstransmission, routers, firewalls, switches, gateway computers and/oredge servers. A network adapter card or network interface in eachcomputing/processing device receives computer readable programinstructions from the network and forwards the computer readable programinstructions for storage in a computer readable storage medium withinthe respective computing/processing device.

Computer readable program instructions for carrying out operations ofthe present invention may be assembler instructions,instruction-set-architecture (ISA) instructions, machine instructions,machine dependent instructions, microcode, firmware instructions,state-setting data, or either source code or object code written in anycombination of one or more programming languages, including an objectoriented programming language such as Smalltalk, C++ or the like, andconventional procedural programming languages, such as the “C”programming language or similar programming languages. The computerreadable program instructions may execute entirely on the user'scomputer, partly on the user's computer, as a stand-alone softwarepackage, partly on the user's computer and partly on a remote computeror entirely on the remote computer or server. In the latter scenario,the remote computer may be connected to the user's computer through anytype of network, including a local area network (LAN) or a wide areanetwork (WAN), or the connection may be made to an external computer(for example, through the Internet using an Internet Service Provider).In some embodiments, electronic circuitry including, for example,programmable logic circuitry, field-programmable gate arrays (FPGA), orprogrammable logic arrays (PLA) may execute the computer readableprogram instructions by utilizing state information of the computerreadable program instructions to personalize the electronic circuitry,in order to perform aspects of the present invention.

Aspects of the present invention are described herein with reference toflowchart illustrations and/or block diagrams of methods, apparatus(systems), and computer program products according to embodiments of theinvention. It will be understood that each block of the flowchartillustrations and/or block diagrams, and combinations of blocks in theflowchart illustrations and/or block diagrams, can be implemented bycomputer readable program instructions.

These computer readable program instructions may be provided to aprocessor of a general purpose computer, special purpose computer, orother programmable data processing apparatus to produce a machine, suchthat the instructions, which execute via the processor of the computeror other programmable data processing apparatus, create means forimplementing the functions/acts specified in the flowchart and/or blockdiagram block or blocks. These computer readable program instructionsmay also be stored in a computer readable storage medium that can directa computer, a programmable data processing apparatus, and/or otherdevices to function in a particular manner, such that the computerreadable storage medium having instructions stored therein comprises anarticle of manufacture including instructions which implement aspects ofthe function/act specified in the flowchart and/or block diagram blockor blocks.

The computer readable program instructions may also be loaded onto acomputer, other programmable data processing apparatus, or other deviceto cause a series of operational steps to be performed on the computer,other programmable apparatus or other device to produce a computerimplemented process, such that the instructions which execute on thecomputer, other programmable apparatus, or other device implement thefunctions/acts specified in the flowchart and/or block diagram block orblocks.

The flowchart and block diagrams in the Figures illustrate thearchitecture, functionality, and operation of possible implementationsof systems, methods, and computer program products according to variousembodiments of the present invention. In this regard, each block in theflowchart or block diagrams may represent a module, segment, or portionof instructions, which comprises one or more executable instructions forimplementing the specified logical function(s). In some alternativeimplementations, the functions noted in the block may occur out of theorder noted in the figures. For example, two blocks shown in successionmay, in fact, be executed substantially concurrently, or the blocks maysometimes be executed in the reverse order, depending upon thefunctionality involved. It will also be noted that each block of theblock diagrams and/or flowchart illustration, and combinations of blocksin the block diagrams and/or flowchart illustration, can be implementedby special purpose hardware-based systems that perform the specifiedfunctions or acts or carry out combinations of special purpose hardwareand computer instructions.

As mentioned herein, an enhancement device according to some embodimentsof the present invention may be installed on or be integral with atypical ETT, for sensing existence of excessive secretion and/or drynessin a patient's trachea lumen and/or a mouth, and for providing suctionand/or wetness as needed.

Reference is now made to FIG. 1, which is a schematic illustration of anETT 10 as known in the art. ETT 10 includes a ventilation tube 12, aventilation inlet 14 and a ventilation outlet 15, which is configured tobe inserted into the trachea. Additionally, ETT 10 includes aninflatable section 16 and an inflation tube 18. Once ETT 10 in insertedvia the mouth or nose of the patient, and ventilation outlet 15 is at adesirable location within the trachea, inflatable section 16 may beinflated by tube 18 until it occupies the entire width of the trachea,within a permitted inflation pressure range, in order to preventinvasion of secretion further into the trachea and the lungs. However,as mentioned above, the obstruction of the trachea by inflatable section16 is not always sufficient and secretion may still penetrate to thelungs through gaps between inflatable section 16 and the trachea walls.

Reference is now made to FIG. 2, which is a schematic illustration of anenhancement device 100 installed on an ETT 10, according to someembodiments of the present invention. Device 100 includes a wrap 30,which may be made, for example, of a biocompatible polymer approved byregulation such as polyurethane, for wrapping ETT 10. Wrap 30 may beinstalled on ETT 10, for example, by snap-fitting, clipping, or slidingof wrap 30 onto ETT 10, or by any other suitable attachment method. Insome embodiments, wrap 30 is tunnel-shaped, with a c-shaped or a majorcircle-arc cross section (as shown, for example, in FIGS. 5 and 7A-7B).In other embodiments, wrap 30 may have a closed circle cross-section.

In some embodiments of the present invention, device 100 is integralwith an ETT device. For example, device 100 illustrated in FIG. 2 may beintegral with ETT 10 and constitute an enhanced ETT device including thefeatures of the ETT and of device 100 described herein, for sensingexistence of excessive secretion and/or dryness in a patient's trachealumen and/or a mouth, and for providing suction and/or wetness asneeded. Accordingly, it will be appreciated that add-on device 100described throughout the present invention is in some embodimentsintegral with an ETT device and constitutes an enhanced ETT device.

At a distal end of wrap 30, device 100 includes a trachea suction port50. When installed on ETT 10, trachea suction port may be located justbefore balloon 16, in order to remove secretion, such as mucus, salivaor pus, before it reaches further in the trachea. Trachea suction port50 may include, for example, one or more trachea suction inlets 51 forremoval of secretion and/or mucus from the trachea, CO2 inlet fordetection of CO2 in the trachea (shown, for example, in FIG. 5), and amoisture sensor 53 for detecting of secretion fluid. In some embodimentsof the present invention, the outer surface of the distal end of devicewrap 30 is smooth and/or tapered, thus facilitating easy insertion ofwrap 30 into the trachea.

Device 100 may also include a mouth pipe 32 for removal of secretionand/or mucus from the mouth, which may also include a moisture sensorfor detecting of secretion fluid. In some embodiments, device 100 mayinclude a liquid outlet 35, for providing liquid, possibly disinfectingfluid, into the mouth in order to avoid excessive dryness and/orinfection, for example by spraying the fluid into the mouth. Forexample, the spray liquid can range from water to mouthwash or othermedicated fluid. In some embodiments, device 100 may include one or moreadditional sensors at the distal end of wrap 30 or in the vicinity ofmouth tube 32, such as, for example, a sensor of temperature, manometry,light, acidity level, sound, and/or any other suitable sensor.

At a proximal end, device 100 may include an outlet bundle 58, includingsecretion suction tubes 63 and 65, a liquid channel 64, a CO2 detectionchannel 66, sensor data wires 68, and/or any other suitable transmissionpipe from and/or into device 100. Suction tubes 63 and 65, liquidchannel 64, CO2 channel 66 and or sensor data wires 68 may be controlledby a hub 60, which may include a controller circuit 75 and/or aprocessor 79, described in more detail with reference to FIG. 4.

FIG. 4 is a schematic illustration of hub 60 according to someembodiments of the present invention. Hub 60 may receive sensor data viasensor data wires 68 and/or CO2 detection data, and control based on thereceived data the liquid supply and/or the secretion suction. In someembodiments, hub 60 may control inflation of balloon 16 via inflationtube 18, with air from an air source 80, as shown in FIG. 2.

For example, typical impedance values detected by the moisture sensorsmay range from more than 1000 Ohm for a dry environment to about 100 Ohmfor wet environment, or some intermediate impedance value.

Suction tubes 63 and 65 may include a distal secretion suction tube anda mouth secretion suction tube, as shown in more detail in FIG. 5. Hub60 may control the secretion suction operation by a pinch valve 72.Pinch valve 72 may control the flow in suction tubes 63 and 65 or in amain suction tube 70, from which suction tubes 63 and 65 may split.Suction tubes 63 and 65 may be controlled separately by hub 60, forexample by a selection valve 74. Suction pressure may be regulated by anavailable vacuum source, from which main suction tube 70 may provide thevacuum.

During operation, wrap 30 is installed over ETT 10 and placed within apatient's body lumen, for example along the trachea through the mouth ornose. Reference is now made to FIG. 3, which is a schematic flowchartillustrating a method 300 for controlling an enhancement device 100according to some embodiments of the present invention. As indicated inblock 310, controller 75 may activate a moisture detector 71, which mayreceive, for example, impedance data from detector electrode pairs 34and 52 via wires 68. As indicated in block 320, in case excessivewetness is detected at electrode mouth pair 34 and/or distal pair 52, acorresponding signal may be sent to controller 75/processor 79, whichmay activate suction by opening pinch valve 72, and/or may operateselection valve 74 to activate suction from the mouth, from the trachea,or both. Controller 75/processor 79 may detect excessive wetness when itexceeds a pre-determined threshold. As indicated in block 330, thesuction may be activated as long as a predetermined condition isfulfilled, for example, for a pre-determined period of time, or untilthe sensor data indicates normal wetness, or wetness below apre-determined threshold, in which case controller 75 may deactivate thesuction.

Controller circuit 75 may be controlled by processor 79, which may beexternal or internal to hub 60.

In order to prevent excessive dryness in the mouth, controller 75 mayactivate a liquid source 73 to provide liquid to liquid outlet 35 vialiquid channel 64. Liquid source 73 may be activated in a predeterminedtime intervals, manually and/or according to sensor data. The liquidprovided by source 73 may include water and/or an oral care solution, toavoid mouth infections. In some embodiments, hub 60 includes an aircompressor 73 a. Controller 75 may activate air compressor 73 a to pushair forcefully into liquid source 73, which as result pushes liquidforcefully through liquid channel 64, and create spray effect out ofliquid outlet 35.

In some embodiments of the present invention, device 100 may detect airleakage from balloon 16. Hub 60 may include a CO2 level sensor 77. CO2sensor 77 may receive a sample of air from the vicinity of balloon 16,via CO2 tube 66, and measure the CO2 level in the sample. As describedbelow with reference to FIG. 5, trachea suction port 50 may include CO2inlet 54, through which the air sample is taken. From the measured CO2levels, controller 75 may detect an unwanted gap between the tracheawall and balloon 16, by deducing when air is leaked from balloon 16.

Reference is now made to FIG. 5, which is a schematic more detailedillustration of add-on device 100 and an exemplary cross-section of aproximal end of wrap 30 according to some embodiments of the presentinvention. Wrap 30 may include a longitudinal opening 31, making thecross-section of wrap 30 c-shaped and/or major arc-shaped andfacilitating installation of wrap 30 on ETT 10. Trachea suction port 50may include, for example, one or more trachea suction inlets 51 forremoval of secretion and/or mucus from the trachea, and/or CO2 inlet 54for detection of CO2 from the trachea by taking a sample of the air inproximity to balloon 16.

In some embodiments of the present invention, additional or alternativesuction port(s) 50 is located along wrap 30 to prevent liquid fromentering through longitudinal opening 31. In some embodiments, wrap 30includes along longitudinal opening 31 a liquid absorbing and/orexpanding material, such as a sponge, as described in PCT publication WO2011/117854 A3. Moisture sensor 53 may include detector electrode pair52. Mouth pipe 32 may include a suction opening 33 for removal ofsecretion and/or mucus from the mouth and a moisture sensor fordetecting of secretion fluid, including a detector electrode pair 34.

Wrap 30 may include a core 40 of thickness d, i.e. the thickness of wrap30 between the external and internal perimeters of wrap 30. Within core40 passes a plurality of longitudinal suction cavities, pipes and/ordetector wires passing along wrap 30. As mentioned herein, the varioussuction cavities may accumulate and remove secretion and/or mucus fromthe mouth and/or from the trachea. Other pipes may be used fortransmission of air sampling out of the trachea, transmission of liquidsto the mouth and/or transmission of other suitable materials out of orinto the trachea and/or the mouth as needed. In some embodiments, wrap30 may include, within core 40, secretion suction cavities 41 and 42 forthe trachea and mouth, respectively, a CO2 sampling pipe 44, liquid pipe45, detector electrode pairs 34 and 52, and/or any other suitable pipesand/or wires.

Detector electrode pairs 34 and 52 may be used for impedancemeasurements in the trachea and/or mouth, for example for detection ofmoisture levels in the trachea and/or mouth and/or in order to identifysecretion and/or excessive dryness. Based on the impedance measurements,a controller may determine whether to activate suction via cavities 41and 42 and/or transmission of liquids via liquid pipe 45 to liquidoutlet 35.

Reference is now made to FIG. 6, which is a schematic more detailedillustration of outlet bundle 58, according to some embodiments of thepresent invention. Outlet bundle 58 may extend out from the proximal endof wrap 30 and guide the various suction and data channels out of thepatient's mouth, to external sources such as a vacuum source and/or hub60. An external trachea suction tube 61 and a mouth suction tube 62 mayprovide suction to cavities 41 and 42 shown in FIG. 5, respectively, forexample from a vacuum source. An external liquid channel 64 may provideliquid to liquid pipe 45 shown in FIG. 5. An external CO2 channel 66 mayeject air sample from CO2 sampling pipe 44 shown in FIG. 5. Data wires68 may transmit sensor data from electrode pairs 34 and 52 shown in FIG.5.

Reference is now made to FIGS. 7A and 7B, which are schematiccross-sectional illustrations of exemplary proximal and distal ends 30 aand 30 b of wrap 30, respectively, according to some embodiments of thepresent invention. As described above, wrap 30 may have a c-shaped or amajor circle-arc cross-section, including a core 40 in which a pluralityof detector electrode pairs 34 and 52 and suction cavities 41 and 42 maybe formed, possibly along with any additional suitable pipes and/orchannels. A longitudinal opening 31 may facilitate the mounting of wrap30 upon ETT 10. Proximal end 30 a is located before mouth pipe 32, andtherefore, as shown in FIG. 7A, assembles both mouth and distal detectorelectrode pairs 34 and 52, and both mouth and distal suction cavities 42and 41, as well as any additional pipes and channels, which may passthrough wrap 30 and be guided out of the patient's mouth. Distal end 30b, as shown in FIG. 7B, may include trachea suction inlets 51 and thedistal end of detector electrode pair 52, as well as any additionalinlets such as, for example, a CO2 sampling inlet.

Reference is now made to FIGS. 8A-8D, which are additional schematicviews of add-on device 100, according to some embodiments of the presentinvention.

FIGS. 8A and 8B are more detailed illustrations of distal end 30 b,according to some embodiments of the present invention. As shown in FIG.8A, distal end 30 b may include a recess 55. Recess 55 may be formed indistal end 30 b, for example in an internal wall of wrap 30. Whensuction is provided through inlet 51, a wall of the trachea may collapsetowards inlet 51. Recess 55 may provide air opening that may preventclogging of inlet 51 by the collapsed trachea wall. Electrode pair 52may be disposed within a depression in a rim of distal end 30 b. Asshown in FIG. 8B, in some embodiments, recess 55 opens inlet 51 from theside, so that suction through inlet 51 is enabled even when distal end30 b is in close proximity to the trachea wall.

FIGS. 8C and 8D are more detailed illustrations of a portion of wrap 30including mouth suction tube 32 and liquid outlet 35, according to someembodiments of the present invention, and a cross-section of wrap 30 ata location between bundle 58 and mouth suction tube 32, according tosome embodiments of the present invention. In some embodiments of thepresent invention, mouth suction tube 32 and/or liquid outlet 35 areconnected to wrap 30 by axes 32 a and 35 a, respectively, perpendicularto wrap 30. In some embodiments of the present invention, mouth suctiontube 32 and/or liquid outlet 35 protrude from wrap 30 and curved towardtheir distal ends. Mouth suction tube 32 and/or liquid outlet 35 can betilted about their respective axis. This way, the direction of tube 32and/or outlet 35 may be adjusted in the patient's mouth.

As described herein, electrode pair 34 and/or one or more other sensorsmay be located on tube 32, proximately to or at opening 33. As describedherein, sensor data channels including detector electrode pairs 34 and52, and mouth and distal suction cavities 42 and 41, may pass withincore 40 of wrap 30 towards bundle 58 and/or hub 60. In some embodiments,CO2 sampling pipe 44, liquid pipe 45, and/or any other suitable pipesand/or wires, pass within core 40.

Reference is now made to FIGS. 9A and 9B, which are schematiccross-sectional illustrations of an exemplary wrap 30 including a liquidabsorbing material 90 according to some embodiments of the presentinvention, before and after liquid absorbing, respectively. Wrap 30 mayinclude along longitudinal opening 31 a liquid absorbing material 90,such as a sponge or foam, for example as described in PCT publication WO2011/117854 A3. For example, material 90 may be laid out along twoopposing sides of opening 31. In some embodiments, wrap 30 includesrecesses 31 a in two opposing sides of opening 31, in which material 90is laid. Material 90 has an expanded state and an unexpanded state,shown in FIGS. 9B and 9A, respectively.

Material 90 takes the expanded state when absorbing liquid. Beforeinsertion of wrap 30 into the trachea, as shown in FIG. 9A, material 90is substantially dry and unexpanded, keeping opening 31 open and thus,for example, enabling snap-fitting, clipping, or sliding of wrap 30 ontoETT 10. After insertion of wrap 30 into the trachea, as shown in FIG.9B, wrap 30 is in a moist environment and material 90 may absorb fluidsand expand, filling opening 31. The expanded material 90 provides bettergrip of wrap 30 on ETT 10 and assists in preventing penetration ofsecretion into the lungs and/or between wrap 30 and ETT 10. The methodsas described above are used in the fabrication of integrated circuitchips.

The descriptions of the various embodiments of the present inventionhave been presented for purposes of illustration, but are not intendedto be exhaustive or limited to the embodiments disclosed. Manymodifications and variations will be apparent to those of ordinary skillin the art without departing from the scope and spirit of the describedembodiments. The terminology used herein was chosen to best explain theprinciples of the embodiments, the practical application or technicalimprovement over technologies found in the marketplace, or to enableothers of ordinary skill in the art to understand the embodimentsdisclosed herein.

As used herein the term “about” refers to ±10%.

The terms “comprises”, “comprising”, “includes”, “including”, “having”and their conjugates mean “including but not limited to”. This termencompasses the terms “consisting of” and “consisting essentially of”.

The phrase “consisting essentially of” means that the composition ormethod may include additional ingredients and/or steps, but only if theadditional ingredients and/or steps do not materially alter the basicand novel characteristics of the claimed composition or method.

As used herein, the singular form “a”, “an” and “the” include pluralreferences unless the context clearly dictates otherwise. For example,the term “a compound” or “at least one compound” may include a pluralityof compounds, including mixtures thereof.

The word “exemplary” is used herein to mean “serving as an example,instance or illustration”. Any embodiment described as “exemplary” isnot necessarily to be construed as preferred or advantageous over otherembodiments and/or to exclude the incorporation of features from otherembodiments.

The word “optionally” is used herein to mean “is provided in someembodiments and not provided in other embodiments”. Any particularembodiment of the invention may include a plurality of “optional”features unless such features conflict.

Throughout this application, various embodiments of this invention maybe presented in a range format. It should be understood that thedescription in range format is merely for convenience and brevity andshould not be construed as an inflexible limitation on the scope of theinvention. Accordingly, the description of a range should be consideredto have specifically disclosed all the possible subranges as well asindividual numerical values within that range. For example, descriptionof a range such as from 1 to 6 should be considered to have specificallydisclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numberswithin that range, for example, 1, 2, 3, 4, 5, and 6. This appliesregardless of the breadth of the range.

Whenever a numerical range is indicated herein, it is meant to includeany cited numeral (fractional or integral) within the indicated range.The phrases “ranging/ranges between” a first indicate number and asecond indicate number and “ranging/ranges from” a first indicate number“to” a second indicate number are used herein interchangeably and aremeant to include the first and second indicated numbers and all thefractional and integral numerals therebetween.

It is appreciated that certain features of the invention, which are, forclarity, described in the context of separate embodiments, may also beprovided in combination in a single embodiment. Conversely, variousfeatures of the invention, which are, for brevity, described in thecontext of a single embodiment, may also be provided separately or inany suitable subcombination or as suitable in any other describedembodiment of the invention. Certain features described in the contextof various embodiments are not to be considered essential features ofthose embodiments, unless the embodiment is inoperative without thoseelements.

Although the invention has been described in conjunction with specificembodiments thereof, it is evident that many alternatives, modificationsand variations will be apparent to those skilled in the art.Accordingly, it is intended to embrace all such alternatives,modifications and variations that fall within the spirit and broad scopeof the appended claims.

It is the intent of the applicant(s) that all publications, patents andpatent applications referred to in this specification are to beincorporated in their entirety by reference into the specification, asif each individual publication, patent or patent application wasspecifically and individually noted when referenced that it is to beincorporated herein by reference. In addition, citation oridentification of any reference in this application shall not beconstrued as an admission that such reference is available as prior artto the present invention. To the extent that section headings are used,they should not be construed as necessarily limiting. In addition, anypriority document(s) of this application is/are hereby incorporatedherein by reference in its/their entirety.

What is claimed is:
 1. An add-on device for a ventilation tube, theadd-on device comprising: a lengthy body having a longitudinal slitsized and shaped to fit over the ventilation tube while the ventilationtube is located within a trachea of a ventilated patient; a plurality ofdiscrete longitudinal cavities including at least one CO₂ sampling pipeand at least two suction cavities passing within a core of thickness ofa cross section of the lengthy body; a CO₂ inlet at a distal end of thelengthy body continuous with the at least one CO₂ sampling pipe, and atleast two suction inlets at the distal end of the lengthy bodycontinuous with the at least two suction cavities and located adjacentto the CO₂ inlet, wherein the at least two suction cavities have anarc-shaped cross section passing along the core of thickness of thelengthy body, and the at least two suction inlets have the arc-shapedcross section, wherein the CO₂ inlet and the at least two suction inletsare positioned proximal to and in a vicinity of a balloon of theventilation tube when in use; a CO₂ level sensor for measuring CO₂ levelwithin a sample of air of the at least one sampling pipe; and acontroller that receives data from the CO₂ level sensor, andautomatically inflates or deflates the balloon on a distal end portionof the ventilation tube according to the received data, and createssuction in the at least two suction cavities via the at least twosuction inlets when indicated, wherein prior to use the add-on device isseparated from the balloon and the ventilation tube, the balloon beingexternal to the add-on device, and when in use the add-on device isconnected to the ventilation tube and positioned proximal to the balloonand senses CO₂ leakage from lungs proximal to the balloon via the CO₂inlet for automation inflation or deflation of the balloon.
 2. Theadd-on device of claim 1, wherein the CO₂ inlet is located along a samecircumference plane of the distal end of the lengthy body as the atleast two suction inlets.
 3. The add-on device of claim 1, wherein asize of the CO₂ inlet is smaller than a size of the at least two suctioninlets.
 4. The add-on device of claim 1, further comprising an impedancesensor for detection of liquid, disposed at the distal end of thelengthy body, wherein the CO₂ inlet is located between the impedancesensor and the at least two suction inlets.
 5. The add-on device ofclaim 4, wherein the CO₂ inlet, the impedance sensor, and the at leasttwo suction inlets, are located along a same circumference plane of thedistal end of the lengthy body.
 6. The add-on device of claim 1, whereinthe CO₂ inlet is oval shaped, and the suction inlet is rectangularshaped.
 7. The add-on device of claim 1, wherein the at least one CO₂sampling pipe has a circular cross section passing along the core ofthickness of a wall of the lengthy body.
 8. The add-on device of claim1, wherein the at least one CO₂ sampling pipe is positioned between twosuction cavities within the core of thickness of the lengthy body. 9.The add-on device of claim 1, further comprising an outlet bundleextending out from a proximal end of the lengthy body, the outlet bundleincluding tubes that are extensions of the at least one CO₂ samplingpipe and the at least two suction cavities, wherein the outlet bundle isconnected to the controller.
 10. The add-on device of claim 9, whereinthe outlet bundle further includes wires connected to at least oneimpedance sensor disposed on the distal end of the lengthy body, thewires passing within the core of thickness of the cross section of awall of the lengthy body and spaced apart from the plurality of discretelongitudinal cavities.
 11. The add-on device of claim 1, wherein thedistal end of the lengthy body comprises a tapered portion, the lengthybody terminating at an end of the tapered portion, wherein the CO₂ inletis disposed on the tapered portion.
 12. The add-on device of claim 1,wherein the controller is adapted to detect air leakage from lungs ofthe ventilated patient according to the data from the CO₂ level sensorfor sensing of CO₂ gas indicating the air leakage.
 13. The add-on deviceof claim 1, wherein the controller is configured to detect a gap betweenthe trachea wall and the balloon of the ventilation tube according tothe data from the CO₂ level sensor for sensing of leak indicating CO₂gas.
 14. The add-on device of the claim 1, further comprising a hub thatincludes the controller, the CO₂ level sensor, a connector to aninflation tube connected to the balloon, and an air source for inflationof the balloon via the inflation tube.
 15. The add-on device of claim 1,wherein the controller inflates the balloon until data from the CO₂level sensor for sensing of CO₂ gas indicates termination of a leakageof CO₂.
 16. The add-on device of claim 1, wherein the ventilation tubecomprises an Endo-Tracheal Tube (ETT).
 17. The add-on device of claim 1,wherein the controller adjusts pressure in the balloon within apermitted pressure range according to the received data.